The Discontinuation of Brand-Name Lamisil
The brand name medication Lamisil, containing the active ingredient terbinafine, was once a well-known treatment for fungal infections. However, its manufacturer, Novartis, made the decision to discontinue certain formulations of the drug. Specifically, the company announced the discontinuation of the 250mg oral tablets and earlier, oral granules in the US. This decision was reportedly a business strategy, with Novartis confirming it was not related to any manufacturing, product quality, safety, or efficacy concerns. The expiration of the patent for Lamisil in 2007 paved the way for generic versions to enter the market, which likely influenced the company's business decision. The rise of generic competition often leads to brand-name drugs becoming commercially less viable for the original patent holder.
The Widespread Availability of Generic Terbinafine
For patients and healthcare providers, the discontinuation of brand-name Lamisil has had minimal impact on treatment options. The reason is the robust and competitive market for generic drugs. Generic versions of terbinafine were approved by the FDA as early as 2007, and multiple manufacturers now produce them. Generic drugs are required to have the same active ingredient, strength, quality, and performance as their brand-name counterparts, meaning they are therapeutically equivalent. This has made terbinafine more accessible and affordable than ever before.
Oral vs. Topical Terbinafine
It's also important to distinguish between the forms of terbinafine. Both prescription oral tablets and over-the-counter (OTC) topical treatments are available in generic form.
- Prescription Oral Tablets: Used for systemic fungal infections, most notably onychomycosis (fungal nail infection). Patients still need a prescription for these tablets, but they will be receiving a generic version of the medication.
- Over-the-Counter Topical Treatments: Available as creams, gels, and sprays, these are used for more superficial skin infections like athlete's foot (tinea pedis) and jock itch (tinea cruris). Many OTC products still carry branding that connects them to the Lamisil name (e.g., Lamisil AT) but are also available generically.
Understanding the Difference: Brand vs. Generic
To clear up any confusion, it's helpful to understand the distinction between brand-name and generic drugs. In the case of terbinafine, the brand-name product was Lamisil. After the patent expired, other companies could produce the same chemical compound (terbinafine) and sell it under its generic name. While the active ingredient is identical, there can be minor variations in inactive ingredients like fillers or dyes, which do not affect the drug's effectiveness.
| Feature | Brand-Name Lamisil (Oral) | Generic Terbinafine (Oral) |
|---|---|---|
| Manufacturer | Novartis | Multiple generic manufacturers |
| Availability | Discontinued in most markets | Widely available |
| Active Ingredient | Terbinafine hydrochloride | Terbinafine hydrochloride |
| Bioequivalence | N/A | Considered therapeutically equivalent to brand-name |
| Cost | Was premium-priced | Much more affordable |
| Reason for Discontinuation | Business decision by manufacturer | N/A |
Potential Reasons for Personal Discontinuation
While the drug itself is not being discontinued, individual patients may need to stop taking oral terbinafine due to adverse effects. The FDA and healthcare providers have issued warnings about specific side effects that require immediate discontinuation.
- Liver Injury: Although rare, severe liver injury, including liver failure, has been reported. Patients experiencing symptoms like persistent nausea, abdominal pain, or jaundice should stop the medication and contact their doctor.
- Taste/Smell Disturbances: Some patients report a partial or complete loss of taste or smell while on oral terbinafine. These side effects can be severe and prolonged, and the medication should be discontinued if they occur.
- Serious Skin Reactions: Severe skin conditions, such as Stevens-Johnson syndrome, are a potential, though rare, side effect that necessitates immediate discontinuation.
Antifungal Alternatives to Terbinafine
For patients where terbinafine is not the best option, either due to side effects or effectiveness, other antifungal medications are available.
Oral Alternatives:
- Itraconazole (Sporanox): Another oral antifungal, though studies sometimes show it to be less effective for nail fungus and it carries different side effects, including heart-related risks.
- Fluconazole: Used for a range of fungal infections, but may be less effective for certain nail infections compared to terbinafine.
- Griseofulvin: An older antifungal that often requires longer treatment courses for nail infections.
Topical Alternatives:
- Ciclopirox (Penlac) nail lacquer: A medicated nail polish that is applied directly to the infected nail.
- Efinaconazole (Jublia) and Tavaborole (Kerydin): Medicated nail creams that are applied topically.
- Clotrimazole (Lotrimin): An OTC topical cream for skin infections like athlete's foot and jock itch.
Conclusion
To answer the question, "Is terbinafine being discontinued?" the clear answer is no. While its well-known brand-name, Lamisil, was retired by its manufacturer, the drug itself lives on as a readily available and affordable generic. The change reflects a shift in the pharmaceutical market towards generic availability rather than an issue with the medication's safety or efficacy. Patients who previously used brand-name Lamisil can confidently continue their treatment with generic terbinafine. For those who cannot tolerate the medication due to specific side effects, or for whom it is not effective, a range of alternative oral and topical antifungals remains available under the guidance of a healthcare professional. Generic terbinafine continues to be a cornerstone of antifungal treatment for millions worldwide.
Sources
- GoodRx: Terbinafine 2025 Prices, Coupons & Savings Tips
- Drugs.com: Generic Lamisil Availability
- MPR: Antifungal Tablets to Be Discontinued
- FDA: accessdata.fda.gov, Lamisil (terbinafine hydroloride) tablets label
- ABC News: Generic Lamisil Approved
